FDA approves Kremers Urban generic ADHD drug
PRINCETON, N.J. — The Food and Drug Administration has approved a Kremers Urban Pharmaceuticals drug for treating attention deficit hyperactivity disorder, the UCB subsidiary said.
KU announced the approval of methylphenidate hydrochloride extended-release tablets in the 18-mg and 27-mg strengths.
The drug is a generic version of Johnson & Johnson's Concerta QD.
The company also received tentative approval from the FDA for the 36-mg and 54-mg strengths of the drug and will be allowed to receive final approval after the expiration of the exclusivity period for the drug in September 2013.